Multiple Myeloma
Conditions
Keywords
CAR-T cells
Brief summary
Phase 1 of the study is comprised of an open-label, single ascending dose (SAD), multiple cohort study; a multiple dose cycle administration cohort study; and a combination administration study of P-BCMA-101 autologous T stem cell memory (Tscm) CAR-T cells in patients with relapsed / refractory MM. Followed by a Phase 2, open-label, efficacy and safety study. Rimiducid may be administered as indicated.
Detailed description
Phase 1 follows a 3 + 3 design of dose-escalating cohorts. Phase 2 of the study is an open-label multi-center efficacy and safety study. After a patient enrolls, leukapheresis will be performed to obtain peripheral blood mononuclear cells which will be sent to a manufacturing site to produce P-BCMA-101 CAR-T cells. The cells will then be returned to the investigational site and, after a standard chemotherapy based conditioning regimen, will be administered to the patient across 1-3 infusions, with or without combination therapy. Treated patients will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated.
Interventions
BIOLOGICALP-BCMA-101 CAR-T cells
P-BCMA-101 is an autologous, principally Tscm, CAR-T cell product (also called called a CARTyrin T cell product) targeting the myeloma selective protein BCMA. P-BCMA-101 cells are produced using a non-viral vector carrying the gene for an anti-BCMA Centyrin-based (small, fully human binding domain, designed to increase T cell persistence and decrease exhaustion) chimeric antigen receptor (CAR). Secondary to the large carrying capacity of the non-viral vector, P-BCMA-101 cells carry two additional genes, a selection gene used to manufacture a purified product and a safety switch gene to allow the cells to be eliminated if desired. Rimiducid (safety switch activator) may be administered as indicated.
DRUGRimiducid
Rimiducid (safety switch activator) may be administered as indicated.
Sponsors
California Institute for Regenerative Medicine (CIRM)
Poseida Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase 1: open label, 3 + 3 design of dose-escalating cohorts Phase 2: open label, administered as a total dose
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females, ≥18 years of age * Must have a confirmed diagnosis of active MM * Must have measurable MM * Must have relapsed / refractory MM, having received treatment with proteasome inhibitor and IMiD \[Phase 2: Must have relapsed / refractory MM, and refractory to last line of therapy, having received treatment with proteasome inhibitor, an IMiD, CD38 targeted therapy and undergone autologous stem cell transplant (ASCT) or not a candidate for ASCT.\] * Must have adequate hepatic, renal, cardiac and hematopoietic function
Exclusion criteria
* Is pregnant or lactating * Has inadequate venous access and/or contraindications to leukapheresis * Has active hemolytic anemia, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, disseminated intravascular coagulation, leukostasis, amyloidosis, significant autoimmune, CNS or other malignant disease * Has an active second malignancy (not disease-free for at least 5 years) in addition to MM, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma. * Has active autoimmune disease * Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy, etc. * Has an active systemic infection * Has hepatitis B or C virus, human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection, or any immunodeficiency syndrome. * Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol * Has receiving immunosuppressive or other contraindicated therapies within the excluded time frame from entry * Has CNS metastases or symptomatic CNS involvement * Has a history of having undergone allogeneic stem cell transplantation, or any other allogeneic or xenogeneic transplant, or has undergone autologous transplantation within 90 days. * Unable to take acetylsalicylic acid (ASA) daily as prophylactic anticoagulation. (Cohorts R and RP only). * History of thromboembolic disease within the past 6 months, regardless of anticoagulation (Cohorts R and RP only).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Assess the Safety of P-BCMA-101 | Baseline through Day 28 | Incidence and severity of treatment-emergent adverse events |
| Phase 1: Maximum Tolerated Dose of P-BCMA-101 | Baseline through Day 28 | Rate of dose limiting toxicities (DLT) |
| Phase 2: Assess the Safety of P-BCMA-101 | Baseline through 24 months | Incidence and severity of treatment-emergent adverse events |
| Phase 2: Assess the Efficacy of P-BCMA-101 (ORR) | Baseline through 24 months | According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR). |
| Phase 2: Assess the Efficacy of P-BCMA-101 (DOR) | Baseline through 24 months | According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Duration of Response (DOR)-Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Anti-myeloma Effect of P-BCMA-101 (PFS) | Baseline through Month 24 | According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Progression Free Survival (PFS)-Time from P-BCMA-101 treatment to progressive disease. |
| Phase 1: Anti-myeloma Effect of P-BCMA-101 (OS) | Baseline through Month 24 | According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Survival (OS)-Duration of survival from time of treatment with P-BCMA-101. |
| Phase 1: The Effect of Cell Dose to Guide Selection of Doses for Further Assessment in Phase 2/3 Studies | Baseline through Month 24 | Incidence and severity of CRS events graded using Lee criteria (Lee, 2014) |
| Phase 2: Incidence and Severity of Cytokine Release Syndrome (CRS) | Baseline through Month 24 | Incidence and severity of CRS events graded using Lee criteria (Lee, 2014) |
| Phase 2: Evaluate Efficacy Endpoints (IL-6) | Baseline through Month 24 | Rate of IL-6 antagonist |
| Phase 1:Assess the Safety of P-BCMA-101 | Baseline through Month 24 | Incidence and severity of treatment-emergent adverse events |
| Phase 2: Evaluate Efficacy Endpoints (R) | Baseline through Month 24 | Rimiducid Use |
| Phase 2: Evaluate Efficacy Endpoints (OS) | Baseline through Month 24 | According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Survival (OS)-Duration of survival from time of treatment with P-BCMA-101. |
| Phase 2: Evaluate Efficacy Endpoints (PFS) | Baseline through Month 24 | According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Progression Free Survival (PFS)-Time from P-BCMA-101 treatment to progressive disease. |
| Phase 2: Evaluate Efficacy Endpoints (TTR) | Baseline through Month 24 | According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Time to Response (TTR)-Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease. |
| Phase 2: Evaluate Efficacy Endpoints (MRD) | Baseline through Month 24 | Minimum residual disease negative rate |
| Phase 2: Evaluate Efficacy Endpoints (C) | Baseline through Month 24 | Corticosteroid Use |
| Phase 1:Assess the Feasibility P-BCMA-101 | Baseline through Month 24 | Ability to generate protocol-prescribed doses of P-BCMA-101. |
| Phase 1: Anti-myeloma Effect of P-BCMA-101 (ORR) | Baseline through Month 24 | According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR). |
| Phase 1: Anti-myeloma Effect of P-BCMA-101 (TTR) | Baseline through Month 24 | According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Time to Response (TTR)-Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease. |
| Phase 1: Anti-myeloma Effect of P-BCMA-101 (DOR) | Baseline through Month 24 | According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Duration of Response (DOR)-Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phase 1: P-BCMA-101 CAR-T Cells Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated. | 69 |
| Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated. | 3 |
| Phase 1 P-BCMA-101 CAR-T Cells (Cohort B) Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated. | 1 |
| Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R) Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated. | 8 |
| Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP) Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated. | 5 |
| Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT) Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated. | 16 |
| Phase 2: P-BCMA-101 CAR-T Cells CAR-T cells administered via intravenous infusion as a total dose | 3 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | other reason not listed above | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Significant progression of malignancy requiring alternative, medical, radiation or surgical interven | 52 | 3 | 1 | 6 | 5 | 10 | 3 |
| Overall Study | Termination of the study by the PI, the sponsor, the study funder, the IRB/IEC or the FDA | 6 | 0 | 0 | 2 | 0 | 4 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 0 | 0 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) | Phase 1 P-BCMA-101 CAR-T Cells (Cohort B) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R) | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP) | Phase 1: P-BCMA-101 CAR-T Cells | Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT) | Phase 2: P-BCMA-101 CAR-T Cells |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 45 Participants | 1 Participants | 0 Participants | 3 Participants | 2 Participants | 30 Participants | 8 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 2 Participants | 1 Participants | 5 Participants | 3 Participants | 39 Participants | 8 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 92 Participants | 3 Participants | 1 Participants | 8 Participants | 3 Participants | 60 Participants | 14 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 13 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 7 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 71 Participants | 1 Participants | 1 Participants | 6 Participants | 3 Participants | 48 Participants | 10 Participants | 2 Participants |
| Region of Enrollment United States | 105 participants | 3 participants | 1 participants | 8 participants | 5 participants | 69 participants | 16 participants | 3 participants |
| Sex: Female, Male Female | 39 Participants | 0 Participants | 1 Participants | 4 Participants | 2 Participants | 23 Participants | 7 Participants | 2 Participants |
| Sex: Female, Male Male | 66 Participants | 3 Participants | 0 Participants | 4 Participants | 3 Participants | 46 Participants | 9 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 23 / 69 | 0 / 3 | 0 / 1 | 3 / 8 | 1 / 5 | 0 / 16 | 1 / 3 | 2 / 5 |
| other Total, other adverse events | 63 / 69 | 3 / 3 | 1 / 1 | 7 / 8 | 5 / 5 | 16 / 16 | 3 / 3 | 4 / 5 |
| serious Total, serious adverse events | 39 / 69 | 1 / 3 | 1 / 1 | 7 / 8 | 2 / 5 | 6 / 16 | 2 / 3 | 2 / 5 |
Outcome results
Primary
Phase 1: Assess the Safety of P-BCMA-101
Incidence and severity of treatment-emergent adverse events
Time frame: Baseline through Day 28
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: P-BCMA-101 CAR-T Cells | Phase 1: Assess the Safety of P-BCMA-101 | TEAE Related to P-BCMA-101 | 56 Participants |
| Phase 1: P-BCMA-101 CAR-T Cells | Phase 1: Assess the Safety of P-BCMA-101 | TEAE Not Related to P-BCMA-101 | 11 Participants |
| Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) | Phase 1: Assess the Safety of P-BCMA-101 | TEAE Related to P-BCMA-101 | 3 Participants |
| Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) | Phase 1: Assess the Safety of P-BCMA-101 | TEAE Not Related to P-BCMA-101 | 0 Participants |
| Phase 1 P-BCMA-101 CAR-T Cells (Cohort B) | Phase 1: Assess the Safety of P-BCMA-101 | TEAE Related to P-BCMA-101 | 0 Participants |
| Phase 1 P-BCMA-101 CAR-T Cells (Cohort B) | Phase 1: Assess the Safety of P-BCMA-101 | TEAE Not Related to P-BCMA-101 | 1 Participants |
| Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R) | Phase 1: Assess the Safety of P-BCMA-101 | TEAE Related to P-BCMA-101 | 7 Participants |
| Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R) | Phase 1: Assess the Safety of P-BCMA-101 | TEAE Not Related to P-BCMA-101 | 1 Participants |
| Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP) | Phase 1: Assess the Safety of P-BCMA-101 | TEAE Related to P-BCMA-101 | 2 Participants |
| Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP) | Phase 1: Assess the Safety of P-BCMA-101 | TEAE Not Related to P-BCMA-101 | 3 Participants |
| Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT) | Phase 1: Assess the Safety of P-BCMA-101 | TEAE Related to P-BCMA-101 | 13 Participants |
| Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT) | Phase 1: Assess the Safety of P-BCMA-101 | TEAE Not Related to P-BCMA-101 | 3 Participants |
Primary
Phase 1: Maximum Tolerated Dose of P-BCMA-101
Rate of dose limiting toxicities (DLT)
Time frame: Baseline through Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1: P-BCMA-101 CAR-T Cells | Phase 1: Maximum Tolerated Dose of P-BCMA-101 | 0 Participants |
| Phase 1 P-BCMA-101 CAR-T Cells (Cohort A) | Phase 1: Maximum Tolerated Dose of P-BCMA-101 | 0 Participants |
| Phase 1 P-BCMA-101 CAR-T Cells (Cohort B) | Phase 1: Maximum Tolerated Dose of P-BCMA-101 | 0 Participants |
| Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R) | Phase 1: Maximum Tolerated Dose of P-BCMA-101 | 0 Participants |
| Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP) | Phase 1: Maximum Tolerated Dose of P-BCMA-101 | 0 Participants |
| Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT) | Phase 1: Maximum Tolerated Dose of P-BCMA-101 | 0 Participants |
| Phase 2: P-BCMA-101 CAR-T Cells | Phase 1: Maximum Tolerated Dose of P-BCMA-101 | NA Participants |
Primary
Phase 2: Assess the Efficacy of P-BCMA-101 (DOR)
According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Duration of Response (DOR)-Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.
Time frame: Baseline through 24 months
Population: Independent Review Committee (IRC) was not formed to assess DOR as the Phase II portion of the study was terminated early to focus on an Allogeneic BCMA CAR-T program.
Primary
Phase 2: Assess the Efficacy of P-BCMA-101 (ORR)
According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR).
Time frame: Baseline through 24 months
Population: Independent Review Committee (IRC) was not formed to assess ORR as the Phase II portion of the study was terminated early to focus on an Allogeneic BCMA CAR-T program.
Primary
Phase 2: Assess the Safety of P-BCMA-101
Incidence and severity of treatment-emergent adverse events
Time frame: Baseline through 24 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: P-BCMA-101 CAR-T Cells | Phase 2: Assess the Safety of P-BCMA-101 | TEAE Related to P-BCMA-101 | 2 Participants |
| Phase 1: P-BCMA-101 CAR-T Cells | Phase 2: Assess the Safety of P-BCMA-101 | TEAE Not Related to P-BCMA-101 | 1 Participants |
Secondary
Phase 1: Anti-myeloma Effect of P-BCMA-101 (DOR)
According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Duration of Response (DOR)-Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.
Time frame: Baseline through Month 24
Secondary
Phase 1: Anti-myeloma Effect of P-BCMA-101 (ORR)
According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR).
Time frame: Baseline through Month 24
Secondary
Phase 1: Anti-myeloma Effect of P-BCMA-101 (OS)
According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Survival (OS)-Duration of survival from time of treatment with P-BCMA-101.
Time frame: Baseline through Month 24
Secondary
Phase 1: Anti-myeloma Effect of P-BCMA-101 (PFS)
According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Progression Free Survival (PFS)-Time from P-BCMA-101 treatment to progressive disease.
Time frame: Baseline through Month 24
Secondary
Phase 1: Anti-myeloma Effect of P-BCMA-101 (TTR)
According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Time to Response (TTR)-Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.
Time frame: Baseline through Month 24
Secondary
Phase 1:Assess the Feasibility P-BCMA-101
Ability to generate protocol-prescribed doses of P-BCMA-101.
Time frame: Baseline through Month 24
Secondary
Phase 1:Assess the Safety of P-BCMA-101
Incidence and severity of treatment-emergent adverse events
Time frame: Baseline through Month 24
Secondary
Phase 1: The Effect of Cell Dose to Guide Selection of Doses for Further Assessment in Phase 2/3 Studies
Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)
Time frame: Baseline through Month 24
Secondary
Phase 2: Evaluate Efficacy Endpoints (C)
Corticosteroid Use
Time frame: Baseline through Month 24
Secondary
Phase 2: Evaluate Efficacy Endpoints (IL-6)
Rate of IL-6 antagonist
Time frame: Baseline through Month 24
Secondary
Phase 2: Evaluate Efficacy Endpoints (MRD)
Minimum residual disease negative rate
Time frame: Baseline through Month 24
Secondary
Phase 2: Evaluate Efficacy Endpoints (OS)
According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Overall Survival (OS)-Duration of survival from time of treatment with P-BCMA-101.
Time frame: Baseline through Month 24
Secondary
Phase 2: Evaluate Efficacy Endpoints (PFS)
According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Progression Free Survival (PFS)-Time from P-BCMA-101 treatment to progressive disease.
Time frame: Baseline through Month 24
Secondary
Phase 2: Evaluate Efficacy Endpoints (R)
Rimiducid Use
Time frame: Baseline through Month 24
Secondary
Phase 2: Evaluate Efficacy Endpoints (TTR)
According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma: Time to Response (TTR)-Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.
Time frame: Baseline through Month 24
Secondary
Phase 2: Incidence and Severity of Cytokine Release Syndrome (CRS)
Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)
Time frame: Baseline through Month 24